User-configurable closed-loop notifications and infusion systems incorporating same

• US 9,861,748 B2
• Filed: 02/06/2014
• Issued: 01/09/2018
• Est. Priority Date: 02/06/2014
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Mastrototaro, John J., Keenan, Desmond Barry, Grosman, Benyamin, Roy, Anirban
• Primary Examiner(s): BERDICHEVSKY, AARTI
• Application Number:
  US14/174,487
• Publication Number:
  US 20150217051A1
• Time in Patent Office: 1,433 Days
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3365 Rotational speed
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/70 with testing or calibration facilities
• CPC Class Codes: A61M 2205/702 automatically during use
• CPC Class Codes: A61M 2205/8212 with means or measures taken for minimising energy consumption
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device capable of delivering fluid to a user involves storing alert configuration information for the user, identifying an alert condition while operating the infusion device to deliver the fluid based at least in part on the alert configuration information for the user, and in response to identifying the alert condition, providing a user notification in accordance with the user'"'"'s stored alert configuration information.

Claims

1. An infusion system comprising:

one or more user interface elements;

a motor operable to deliver fluid to a user, delivery of the fluid influencing a condition of the user;

a sensing arrangement to obtain a sensor value indicative of the condition of the user;

a data storage element to store alert configuration information for the user; and

a control system coupled to the motor, the sensing arrangement, the data storage element, and the one or more user interface elements to;

operate the motor in a closed-loop mode to deliver the fluid to the user based at least in part on a difference between a target value for the condition of the user and the sensor value;

identify an alert condition based at least in part on the alert configuration information for the user while operating the motor in the closed-loop mode; and

in response to identifying the alert condition;

provide a user notification via the one or more user interface elements in accordance with the alert configuration information; and

operate the motor in an alternative control mode;

receive a user response after providing the user notification; and

thereafter operate the motor to deliver the fluid to the user in a manner that is influenced by the user response.

2. The infusion system of claim 1, the alert configuration information identifying a type of user notification to be generated for the alert condition, wherein the control system automatically generates the type of user notification identified by the alert configuration information for the user in response to identifying the alert condition.

3. The infusion system of claim 1, wherein:

the user response comprises an updated blood glucose measurement value for the user from a blood glucose meter; and

the control system reinitializes the closed-loop mode for the motor based at least in part on the updated blood glucose measurement value.

4. The infusion system of claim 1, wherein:

the user response comprises an updated blood glucose measurement value for the user from a blood glucose meter;

the sensing arrangement comprises a glucose sensing arrangement and

the control system;

determines an updated calibration factor for the glucose sensing arrangement based at least in part on the updated blood glucose measurement value; and

reinitializes the closed-loop mode for the motor based at least in part on the updated blood glucose measurement value and the updated calibration factor.

5. The infusion system of claim 1, wherein after providing the user notification, the control system:

receives an updated blood glucose measurement value for the user from a blood glucose meter; and

reinitializes the closed-loop mode based at least in part on the updated blood glucose measurement value.

6. The infusion system of claim 1, the target value comprising a target glucose value for the user and the sensor value comprising a current sensor glucose value for the user, wherein after providing the user notification, the control system:

receives an updated blood glucose measurement value for the user from a blood glucose meter; and

reinitializes the closed-loop mode based at least in part on the updated blood glucose measurement value.

7. The infusion system of claim 1, wherein the control system receives the alert configuration information from the user via the one or more user interface elements and stores the received alert configuration information in the data storage element.

8. The infusion system of claim 1, wherein the control system determines whether the user notification is generated based on the alert configuration information for the user.

9. The infusion system of claim 1, wherein the user notification is generated in a user-specific manner based on the alert configuration information for the user.

10. The infusion system of claim 1, further comprising a blood glucose meter to obtain a blood glucose reference measurement value from the body of the user, wherein:

the response comprises an updated blood glucose reference measurement value; and

the control system is coupled to the blood glucose meter and the sensing arrangement to;

operate the motor in the closed-loop mode based at least in part on an initial blood glucose reference measurement value from the blood glucose meter; and

after providing the user notification;

receive the updated blood glucose reference measurement value for the user from the blood glucose meter; and

provide a second user notification based at least in part on the updated blood glucose reference measurement value via the one or more user interface elements in accordance with the alert configuration information.

11. The infusion system of claim 1, wherein:

the one or more user interface elements comprise;

a first user interface element associated with a first type of user notification; and

a second user interface element associated with a second type of user notification; and

the control system is coupled to the first user interface element and the second user interface element to;

provide the user notification via the first user interface element when the alert configuration information identifies the first type of user notification for the alert condition; and

provide the user notification via the second user interface element when the alert configuration information identifies the second type of user notification for the alert condition.

12. The infusion system of claim 1, further comprising a blood glucose meter to obtain a blood glucose reference measurement value from the body of the user, wherein:

the response comprises an updated blood glucose reference measurement value; and

the control system is coupled to the blood glucose meter and the sensing arrangement to;

operate the motor in the closed-loop mode based at least in part on an initial blood glucose reference measurement value from the blood glucose meter; and

after providing the user notification;

receive the updated blood glucose reference measurement value for the user from the blood glucose meter; and

reinitialize the closed-loop mode based at least in part on the updated blood glucose reference measurement value.

13. The infusion system of claim 12, wherein:

the sensing arrangement comprises a glucose sensing arrangement obtaining the sensor value indicative of a glucose level of the user; and

the control system is coupled to the glucose sensing arrangement to;

operate the motor in the closed-loop mode based at least in part on the difference between the target value for the glucose level of the user and the sensor value using an initial calibration factor for the glucose sensing arrangement; and

after receiving the updated blood glucose reference measurement value;

determine an updated calibration factor for the glucose sensing arrangement based at least in part on the updated blood glucose reference measurement value; and

reinitialize the closed-loop mode based at least in part on the updated blood glucose reference measurement value and the updated calibration factor.

14. The infusion system of claim 1, wherein the control system provides a second user notification in accordance with the alert configuration information in response to receiving the user response.

15. The infusion system of claim 14, wherein:

the user response comprises an updated blood glucose measurement value for the user from a blood glucose meter; and

the second user notification comprises a low blood glucose user notification automatically generated based at least in part on the updated blood glucose measurement value.

16. The infusion system of claim 14, wherein:

the user response comprises an updated blood glucose measurement value for the user from a blood glucose meter; and

the second user notification comprises an anomalous sensor notification automatically generated based at least in part on the updated blood glucose measurement value.

17. The infusion system of claim 1, wherein:

the fluid comprises insulin;

the response comprises an updated blood glucose reference measurement value;

the sensing arrangement comprises a glucose sensing arrangement;

the control system operates the motor in the closed-loop mode to deliver the insulin to the user based on a difference between a target glucose value for the user and a sensor glucose value for the user obtained using the glucose sensing arrangement;

the closed-loop mode is based at least in part on an initial blood glucose reference measurement value for the user and an initial calibration factor for the glucose sensing arrangement; and

after providing the user notification, the control system;

receives the updated blood glucose reference measurement value; and

operates the motor to deliver the insulin to the user in a manner that is influenced by the updated blood glucose reference measurement value.

18. The infusion system of claim 17, wherein operating the motor to deliver the insulin to the user in a manner that is influenced by the updated blood glucose reference measurement value comprises the control system:

determining whether the sensor glucose value corresponds to the updated blood glucose reference measurement value; and

reinitializing the closed-loop mode based at least in part on the updated blood glucose reference measurement value in response to determining the sensor glucose value corresponds to the updated blood glucose reference measurement value.

19. The infusion system of claim 17, wherein operating the motor to deliver the insulin to the user in a manner that is influenced by the updated blood glucose reference measurement value comprises the control system:

determining an updated calibration factor for the glucose sensing arrangement based at least in part on the updated blood glucose reference measurement value; and

reinitializing the closed-loop mode based at least in part on the updated blood glucose reference measurement value and the updated calibration factor.

20. The infusion system of claim 17, wherein operating the motor to deliver the insulin to the user in a manner that is influenced by the updated blood glucose reference measurement value comprises the control system:

identifying an anomalous condition based at least in part on the updated blood glucose reference measurement value and the sensor glucose value;

automatically providing a second user notification indicating the anomalous condition; and

operating the motor in an alternative mode to deliver the insulin to the user independent of the sensor glucose value.